TJ-IRB20230353

About this trial

Last updated 2 years ago

Study ID

TJ-IRB20230353

Status

Not yet recruiting

Type

Interventional

Phase

Phase 4

Placebo

Accepting

18 to 65 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 6 months ago

The goal of this clinical trial is to compare the efficacy of Jinsang Liyan capsule in combination with PPI versus PPI alone for the treatment of Laryngopharyngeal Reflux Disease (LPRD). Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group was treated with Jinsangliyan capsule + rabeprazole enteric-coated tablets, and the control group was treated with Jinsangliyan capsule placebo + rabeprazole enteric-coated tablets. Participants were followed up at 4 weeks and 8 weeks after taking the drug to evaluate the improvement of LPRD symptoms. Researchers will compare Experimental group and control group to see if Jinsang Liyan capsule combined with PPI treatment is superior to PPI treatment alone.

Inclusion Criteria

- The patients who met the clinical diagnostic criteria for LPRD (by asking history and laryngoscopy, RSI score >13 or RFS score >7 points);

- No antacids or gastrointestinal motility drugs were taken within 2 weeks before enrollment.

- Be aged 18-65 years with no gender restriction;

- Patients understood and agreed to participate in this study and signed an informed consent form.

Exclusion Criteria

- complicated with acute upper respiratory tract infection;

- combined with one of the following diseases of the digestive system: peptic ulcer, history of gastroesophageal and duodenal surgery, Zollinger-Ellison syndrome, pyloric obstruction, primary esophageal motility disorders (e.g., achalasia, scleroderma, primary esophageal spasm), drug-induced esophagitis, mycotic esophagitis, gastrointestinal malignant tumor;

- patients with severe primary diseases of heart, brain, liver, lung, kidney, blood and endocrine system, and severe psychosis without effective control;

- those who could not take medicine during pregnancy or lactation, or who were allergic to the drugs used in this study; Or unable to cooperate with medication and complete relevant records due to various circumstances;

- patients who have participated or are participating in other drug clinical trials within three months;

- patients judged by the investigator to be ineligible for trial participation.

Clinical Study of Jinsang Liyan Capsules Combined With PPI in the Treatment of LPRD